SUPPLEMENTARY INFORMATION:

Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3520), federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. The term “collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires federal agencies to publish a 30-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, CMS is publishing this notice that summarizes the following proposed collection(s) of information for public comment:

1. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Examination and Treatment for Emergency Medical Conditions and Women in Labor; Use: Pursuant to regulation sections 488.18, 489.20 and 489.24, during Medicare surveys of hospitals and State agencies CMS will review hospital records for lists of on-call physicians, and will review and obtain the information which must be recorded on hospital medical records for individuals with emergency medical conditions and women in labor, and the emergency department reporting information Medicare participating hospitals and Medicare State survey agencies must pass on to CMS. Additionally, CMS will use the QIO Report assessing whether an individual had an emergency condition and whether the individual was stabilized to determine whether to impose a CMP or physician exclusion sanctions. Without such information, CMS will be unable to make the hospital emergency services compliance determinations that Congress expects CMS to make under sections 1154, 1866 and 1867 of the Act. Form Number: CMS-R-142 (OMB control number: 0938-0667); Frequency: Occasionally; Affected Public: Private Sector; Number of Respondents: 6,149; Total Annual Responses: 6,149; Total Annual Hours: 1. (For policy questions regarding this collection contact Renate Dombrowski at 410-786-4645.)

2. Type of Information Collection Request: Reinstatement with change of a previously approved collection; Title of Information Collection: HIPAA Administrative Simplification Complaint Form; Use: The Health Insurance Portability and Accountability Act (HIPAA) became law in 1996 (Pub. L. 104-191). Subtitle F of Title II of HIPAA, titled “Administrative Simplification,” (A.S.) requires the Secretary of HHS to adopt national standards for certain information-related activities of the health care industry. The HIPAA provisions, by statute, apply only to “covered entities” referred to in section 1320d-2(a)(1) of this title. Responsibility for administering and enforcing the HIPAA A.S. Transactions, Code Sets, Identifiers has been delegated to the Centers for Medicare & Medicaid Services (CMS). This updated information collection will be used to initiate enforcement actions.

This reinstatement request clarifies the removal of the HIPAA Security complaint category. Specifically, the information collection revisions clarify the “Identify the HIPAA Non-Privacy/Security complaint category” section of the complaint form. In this section, complainants are given an opportunity to check the “Unique Identifiers” and “Operating Rules” option to additionally categorize the type of HIPAA complaint being filed. The revised form now includes an option for identifying Unique Identifier and Operating Rules complaints. It also requests email information about filed against entities, if available. Form Number: CMS-10148 (OMB control number: 0938-0948); Frequency: Occasionally; Affected Public: Individuals; Number of Respondents: 500; Total Annual Responses: 500; Total Annual Hours: 500. (For policy questions regarding this collection contact Cecily Austin at 410-786-0895.)